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Medicine (Baltimore). 2017 Jan;96(1):e5702. doi: 10.1097/MD.0000000000005702.

A randomized, multicenter, phase III study of gemcitabine combined with capecitabine versus gemcitabine alone as first-line chemotherapy for advanced pancreatic cancer in South Korea.

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aDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul bDepartment of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu cDepartment of Internal Medicine, Dong-A University College of Medicine, Busan dDepartment of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine eDepartment of Internal Medicine, Korea University College of Medicine fDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul gDepartment of Internal Medicine, Keimyung University School of Medicine hDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu iDigestive Disease Center and Research Institute, Department of Internal Medicine, Soon Chun Hyang University School of Medicine, Bucheon and Seoul jDepartment of Internal Medicine, Pusan National University Hospital, Busan. kDepartments of Internal Medicine, Pusan National University Hospital, Yangsan lDepartment of Internal Medicine, Digestive Disease Centre, Konkuk University School of Medicine, Seoul mDepartments of Internal Medicine, Hanyang University College of Medicine, Seoul nDepartment of Internal Medicine, School of Medicine, Wonkwang University, Iksan oDepartment of Internal Medicine, The Catholic University of Korea College of Medicine, St. Mary's Hospital pBiostatistics Collaboration Unit, Medical Research Center, Yonsei University College of Medicine, Seoul, Korea.



This phase III trial compared the efficacy and safety of gemcitabine plus capecitabine (GemCap) versus single-agent gemcitabine (Gem) in advanced pancreatic cancer as first-line chemotherapy.


A total of 214 advanced pancreatic cancer patients were enrolled from 16 hospitals in South Korea between 2007 and 2011. Patients were randomly assigned to receive GemCap (oral capecitabine 1660 mg/m plus Gem 1000 mg/m by 30-minute intravenous infusion weekly for 3 weeks followed by a 1-week break every 4 weeks) or Gem (by 30-minute intravenous infusion weekly for 3 weeks every 4 weeks).


Median overall survival (OS) time, the primary end point, was 10.3 and 7.5 months in the GemCap and Gem arms, respectively (P = 0.06). Progression-free survival was 6.2 and 5.3 months in the GemCap and Gem arms, respectively (P = 0.08). GemCap significantly improved overall response rate compared with Gem alone (43.7% vs 17.6%; P = 0.001). Overall frequency of grade 3 or 4 toxicities was similar in each group. Neutropenia was the most frequent grade 3 or 4 toxicity in both groups.


GemCap failed to improve OS at a statistically significant level compared to Gem treatment. This study showed a trend toward improved OS compared to Gem alone. GemCap and Gem both exhibited similar safety profiles.

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